Medical Device Sterilization and Disinfection Quiz
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Questions and Answers

What does the term 'sterile' refer to in the context of implantable devices and biomaterials?

  • The weight of the device
  • The type of materials used in the device
  • The presence or absence of microorganisms (correct)
  • The color of the device

    • What is the preferred method when terminal sterilization is not possible due to the addition of biologics or liquids to the device?

  • Reducing the regulatory compliance standards
  • Using a different type of biomaterial
  • Increasing the temperature of terminal sterilization
  • Aseptic processing of the product (correct)

    • From a regulatory perspective, how is the term 'sterile' used?

  • To indicate the manufacturing cost of the device
  • To indicate the device's design standards
  • To indicate the device's color
  • To indicate the probability of an implant or device having a bioburden (correct)

    • What is the binary state of a material with regards to being 'sterile'?

    <p>It is either sterile or has microorganisms</p> Signup and view all the answers

    Why is terminal sterilization often not possible in some cases?

    <p>Due to the addition of biologics or liquids to the device</p> Signup and view all the answers

    What is the term 'sterile' used to indicate from a regulatory perspective?

    <p>The probability of an implant or device having a bioburden</p> Signup and view all the answers

    What is the preferred method when terminal sterilization is not possible due to the addition of biologics or liquids to the device?

    <p>Aseptic processing of the product</p> Signup and view all the answers

    What is the binary state of a material with regards to being 'sterile'?

    <p>A material is either sterile or it has microorganisms</p> Signup and view all the answers

    Why is terminal sterilization often not possible in some cases, especially when biologics or liquids are added to the device?

    <p>Biologics and liquids interfere with the effectiveness of terminal sterilization</p> Signup and view all the answers

    What are the majority of sterilization practices in use today?

    <p>Terminal processes</p> Signup and view all the answers

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